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Leader

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 110, Inc.

Identity

Trade Name
LEADER FDA UDI
Generic Name
Public respirator, single-use FDA UDI
Device Name
LDR Earloop Face Masks 20 single-use FDA UDI
Model / Reference
4559860 FDA UDI
Description
LDR Earloop Face Masks 20 single-use FDA UDI

Identifiers

Catalog Number
4559860 FDA UDI
Primary DI / UDI-DI
00096295122299 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Public respirator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Public respirator, single-use

Leader by Cardinal Health 110, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Public respirator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 110, Inc.

Sources (1)

  • FDA UDI 90ca7596-86a7-47d7-978e-193e8e62621c 35 fields · synced Jun 1, 2026